AccessGUDID - DEVICE: Lazurite Holdings LLC Sterilization Tray (00860001744217)

GUDID

Device Identifier (DI) Information

Brand Name: Lazurite Holdings LLC Sterilization Tray
Version or Model: AF0005-101-10
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Lazurite Holdings LLC

Primary DI Number: 00860001744217
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 088448366 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60490	Video camera surgical microscope system	An assembly of noninvasive devices intended to transmit detailed, magnified, video images from a surgical site (non-specific) to a monitor to facilitate visualization of the surgical site by the surgeon; it may include recording equipment for teaching applications. It typically includes a fibreoptic telescope, illumination hardware, video camera, positioning arm, appropriate hardware/cabling, and may include recording unit, monitor and transportation cart.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCJ	Laparoscope, general & plastic surgery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K213860	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Hydrogen Peroxide

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Short Storage and Transport, between 10 and 75 percent relative humidity
Special Storage Condition, Specify: Short Storage and Transport, between 50 and 106 Kilopascal
Special Storage Condition, Specify: Long Term Storage, between 30 and 75 percent Relative Humidity
Handling Environment Atmospheric Pressure: between 30 and 75 Percent (%) Relative Humidity
Special Storage Condition, Specify: Short Storage and Transport, Between -20 and 30 Degrees Celsius
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Special Storage Condition, Specify: Long Term Storage, between -20 and 20 degrees Celsius
Special Storage Condition, Specify: Long Term Storage, between 70 and 106 Kilopascal
Handling Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cd147967-ad81-4c93-962f-2ab39aaabe83
Public Version Date: June 13, 2022
Public Version Number: 1
DI Record Publish Date: June 05, 2022